A care blueprint for tiny patients: can it ease the stress of major surgery in newborns?
NCT ID NCT07771478
First seen Aug 18, 2026 · Last updated Sep 02, 2026 · Updated 3 times
Summary
This study tests whether a structured care plan called Neonatal Enhanced Recovery After Surgery (nERAS) can help newborns recover better after major non-cardiac surgery. Surgery is very stressful on a baby's body, and the plan bundles evidence-based recommendations to standardize care before, during, and after the operation. Researchers will compare outcomes for babies who received standard care versus those treated under the nERAS pathway, and also check how well healthcare teams adopt the guidelines. The study involves reviewing medical records and may include surveys or interviews with providers and parents.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Neonatal Enhanced Recovery After Surgery (nERAS) care pathway, a bundled set of perioperative care recommendations
- What this could lead to
- If effective, this care pathway could become a standard approach to reduce complications and speed recovery for newborns undergoing major surgery, potentially improving long-term development.
- What could go wrong
- This is an observational implementation study, not a randomized trial, so results may be influenced by differences between sites or time periods. Adoption of the pathway may vary, and long-term benefits are uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Aug 2026
An estimate. Start dates often move.
- Expected to finish
-
Dec 2029
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Neonates receiving care in tertiary-level neonatal intensive care units (NICUs) at participating academic hospitals in Canada and the United Kingdom. Participants will be drawn from infants admitted to these NICUs who require major non-cardiac surgical intervention as part of their routine clinical care. The study population represents a broad and clinically relevant sample of neonates undergoing major surgery within high-acuity NICU settings. In addition, healthcare professionals involved in the perioperative care of neonates at participating sites will be recruited to participate in implementation-focused components of the study, including interviews and focus groups.
- Ages
-
24 to 44 weeks
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria Effectiveness aims: * Consent provided by parent/legal guardian * Infant aged ≥24 weeks gestational age at birth and \<cGA 44 weeks at time of index surgery * Requires major non-cardiac surgery requiring general anesthetic (e.g., thoracotomy, laparotomy, ventriculoperitoneal shunt, choanal atresia repair, etc.) * Admitted preoperatively to a study NICU (HSC, ACH, or GOSH) Implementation aims: * Healthcare providers (surgeons, anesthesiologists, neonatologists, and nurses) who provide direct care for eligible infants described above * Caregivers of eligible infants described above (caregiver role to be defined by family and may include parent(s) and/or extended family members) Exclusion Criteria Effectiveness aims: * Infants undergoing cardiac surgery as sole index surgical intervention, sole minor index surgery (e.g., central line placement, eye exam under anesthesia) * Born at less than 24 weeks estimated gestational age or greater than 44 weeks corrected gestation age on day of index surgery * Intraoperative mortality * Genetic anomaly associated with lethality (e.g., trisomy 13 or 18) * Preoperative ECMO (extra-corporeal membrane oxygenation) cannulation * Fetal intervention (e.g, FETO for CDH) Implementation aims: \- Healthcare providers and/or caregivers who do not consent to participate in Implementation surveys or interviews.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Congenital anomaly are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
3 sites in 2 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8, Canada
-
Great Ormond Street Hospital
London, Greater London, WC1N 3BH, United Kingdom
-
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.